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CAR T-cell Therapy

CAR T Cell Therapy for Brain Cancer

Phase 1

Recruiting

Led By Bilal Omer, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Tumors less than 5 cm in maximum dimension at enrollment

Tumors with sizes between 5 and 5.5 cm are eligible if the tumor was surgically debulked

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 weeks post t cell infusion

Awards & highlights

No Placebo-Only Group

Summary

This trial is for patients with high grade glioma (HGG), diffuse intrinsic pontine glioma (DIPG), medulloblastoma, or another rare brain cancer. Patients will receive an infusion of GD2-C7R T cells, which are special immune cells that have been modified to better recognize and kill cancer cells. Researchers will also evaluate how long the GD2-C7R T cells can be detected in the blood and what effect they have on brain cancer.

Who is the study for?

This trial is for children and young adults aged 1 to 21 with specific brain cancers that have a protein called GD2 on their surface. These include newly diagnosed or recurrent tumors like diffuse midline glioma, high-grade glioma, medulloblastoma, and others. Participants need measurable disease on MRI and a functional score indicating they can perform daily activities at least half the time.

What is being tested?

The study tests genetically modified T cells (a type of immune cell) designed to last longer in the body by adding a gene called C7R. This helps them fight cancer more effectively. The trial involves two methods of infusing these cells: directly into the brain (ICV) and into the vein (IV), after chemotherapy to improve their survival.

What are the potential side effects?

Potential side effects may include reactions related to immune response such as inflammation, fever, fatigue; complications from infusion; possible neurological symptoms due to direct brain infusion; and typical risks associated with chemotherapy used before T cell infusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor is smaller than 5 cm.

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My tumor was between 5 and 5.5 cm but was surgically reduced in size.

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My tumor is newly diagnosed or recurrent and tests positive for GD2 or H3K27M.

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I am between 1 and 21 years old.

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I am expected to be mostly self-caring at the time of treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 weeks post t cell infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12 weeks post t cell infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 weeks post t cell infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose limiting toxicity (DLT) rate

Secondary study objectives

Response rate according to standard criteria

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: C7R-GD2.CAR T cells (Cohort 2)Experimental Treatment1 Intervention

The dose level for autologous cell C7R-GD2.CAR T cell immunotherapy administered via intravenous (IV) infusion was determined in the initial phase of the protocol. The standard IV dosing is 10 million cells/m2 with lymphodepletion chemotherapy.

Group II: C7R-GD2.CAR T cells (Cohort 1)Experimental Treatment1 Intervention

The dose level for autologous cell C7R-GD2.CAR T cells administered via intravenous (IV) infusion was determined in the initial phase of the protocol. The standard IV dose is 10 million cells/m2 with lymphodepletion chemotherapy. In this subsequent phase of the study, the safe dosing levels for autologous cell C7R-GD2.CAR T cell immunotherapy administered intracerebroventricularly (ICV) via ommaya reservoir or programmable VP shunt in combination with subsequent IV doses will be determined.

0 / 5Eligibility criteria met